UK industry/MHRA generics quality forum launches

The British Generics Manufacturers Association (BGMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have established a new forum with the aim of ensuring the manufacturing quality of generic drugs in the UK.

The forum will meet three times a years to share and discuss the latest issues which impact on the quality of generics. The group will bring together the MHRA, generics manufacturers and providers of manufacturing and quality control services. Topics to be covered will include the Agency’s current approaches to inspection, trends and the auditing that companies perform themselves.

Commenting on the initiative, BGMA technical director Paul Fleming said: “as regulatory requirements and supply chains become ever more complex, supporting high quality standards is vitally important for the pharmaceutical industry, patients and the value we deliver to the NHS. From a generic medicines perspective, we wanted to launch something that was closely aligned with the regulator in order to increase mutual understanding as well as share the latest information quickly and easily.”

“Quality is a key component in ensuring that patients get their medicines in a timely and affordable manner. Our forum will provide a vital conduit between industry and the regulator on a topic which is critically important to the successful operation of the generic medicines marketplace in the UK, Europe and internationally,” he added.

The MHRA said that it was “pleased” to support this industry initiative.

‘We are always keen to share knowledge and expertise so that companies can fully understand the regulatory environment in which they operate – this is key to ensuring that safe and high-quality generic medicines are being made and distributed, and provides the trust needed by patients and healthcare professionals to use them,” commented Mark Birse, group manager GMDP inspections at the Agency.

“We are also keen to maintain dialogue directly with industry experts who can also provide important feedback and intelligence from their perspective,” Mr Birse went on.

The forum will be open to members and associate members of the BGMA. Its first meeting will be held on June 4, and the second will take place on November 12.